Formulation, Optimization, and In Vitro Evaluation of Doxorubicin-Loaded Cubosomes for Breast Cancer Therapy

Abstract

Author(s): Anil Kumar Y1*, Kapu Thirumala2, Dileep Kumar Garnipudi3, Kommu Pradeep4, Y. Sirisha5, Naveen Pathakala6, Ramshetty Rajendra Prasad7, A. Rajesh8

Breast cancer remains one of the most commonly diagnosed malignancies and a major cause of cancer-related mortality among women worldwide. Doxorubicin is an anthracycline chemotherapeutic agent widely employed in breast cancer treatment. However, its clinical effectiveness is limited by nonspecific tissue distribution, dose-dependent cardiotoxicity, rapid systemic elimination, and the development of multidrug resistance. Lipid-based nanocarriers may improve the delivery of doxorubicin by modifying its distribution, providing controlled release, and increasing its availability within cancer cells. The present study was designed to formulate, optimize, and evaluate doxorubicin-loaded cubosomes for potential application in breast cancer therapy. Cubosomes were prepared using glyceryl monooleate as the lipid-forming material and poloxamer 407 as the stabilizer through a top-down homogenization and probe-sonication method. The effects of lipid and stabilizer concentrations were evaluated using particle size, polydispersity index, zeta potential, entrapment efficiency, and drug loading as critical formulation parameters. The optimized formulation was further characterized using Fourier-transform infrared spectroscopy, differential scanning calorimetry, X-ray diffraction, and transmission electron microscopy. In vitro drug release was investigated using a dialysis-membrane method, and the resulting data were fitted to mathematical release models. The cytotoxic effects of free doxorubicin, blank cubosomes, and doxorubicin-loaded cubosomes were proposed to be evaluated in MCF-7 breast cancer cells using the MTT assay. The study is expected to determine whether cubosomal encapsulation can provide a physically stable nanosized formulation, sustained doxorubicin release, and improved in vitro anticancer activity. Doxorubicin-loaded cubosomes may represent a promising delivery platform for improving the pharmaceutical performance of doxorubicin; however, their therapeutic and safety advantages require confirmation through reproducible experimental and in vivo investigations.

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